The Lead Data Manager will be responsible for all data management activities in large, complex studies under general supervision, or working under minimal supervision on data management activities for small to medium sized projects.
Communication
- Primary communication point for project teams and company departments with regard to clinical data management
- Communication line for clients/vendors for all data management aspects of clinical projects and clinical data management reporting
Data Management
- Coordination of data management activities within clinical projects related to EDC development, data collection, cleaning, reconciliation, Database Lock, development of final integrated database and generation of final Data Management deliverables.
- Primary responsibility for clinical data management activities within clinical projects, including, but not limited to:
- Study documents review
- Data Management plan and other project-specific guidelines and instructions development and review
- Co-ordinate/perform user acceptance testing
- Development of Data Validation Plan/Edit Check Specifications
- Data entry coordination and supervision, feedback to data entry personnel regarding quality of data entry and other data entry issues
- Data validation, including automatic and manual data inspections, data discrepancies/deficiencies review and resolution, query generation and resolution, feedback to clinical trial teams regarding quality of data
- Non-CRF electronic data handling (receiving, archiving, loading into study database, review and resolution of reconciliation issues, feedback to vendors regarding quality of data and other issues)
- Database edits (paper CRF studies)
- Manual CRF review (non-medical checks)
- Clinical database lock
- Coordination and supervision of processing, dispatch and archiving of CRFs/queries
- Input into design of CRFs and other data collection forms; review Case Report Form design for accuracy and adherence to protocol
- Development of CRF completion guidelines
- Coding medical data with coding dictionaries and coding listings review (Lead DMs with medical/biology background, additional training required)
- SAE reconciliation
- Electronic data transfer (import/export) specifications review and approval
Document Management
- Liaison with Document Center with regard to maintenance of TMF and eTMF
Quality Control
- Database QC checks performance and documentation
- Shared responsibility for preparation and attendance at internal and client/third-party audits/inspections of Data Management
- Shared responsibility for follow-up on and resolution of audit findings pertaining to Data Management
Training
- Training of Assistant Data Managers
- Project-specific training of investigators and clinical team in CRF completion
Corporate/Departmental Assignments
- Investigator Meetings preparation/attendance
- Meetings and teleconferences organized by client/vendor preparation/attendance